[Federal Register Volume 81, Number 99 (Monday, May 23, 2016)]
[Notices]
[Pages 32333-32335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-12009]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-16-0950; Docket No. CDC-2016-0044]
Proposed Data Collection Submitted for Public Comment and
Recommendations
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice with comment period.
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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part
of its continuing efforts to reduce public burden and maximize the
utility of government information, invites the general public and other
Federal agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. This notice invites comment on the proposed
revision of the National Health and Nutrition Examination Survey
(NHANES). NHANES programs produce descriptive statistics which measure
the health and nutrition status of the general population.
DATES: Written comments must be received on or before July 22, 2016.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0044 by any of the following methods:
Federal eRulemaking Portal: Regulation.gov. Follow the
instructions for submitting comments.
Mail: Leroy A. Richardson, Information Collection Review
Office, Centers for Disease Control and Prevention, 1600 Clifton Road
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to Regulations.gov, including any personal information
provided. For access to the docket to read background documents or
comments received, go to Regulations.gov.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the information collection plan
and instruments, contact the Information Collection Review Office,
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from
the Office of Management and Budget (OMB) for each collection of
information they conduct or sponsor. In addition, the PRA also requires
Federal agencies to provide a 60-day notice in the Federal Register
concerning each proposed collection of information, including each new
proposed collection, each proposed extension of existing collection of
information, and each reinstatement of previously approved information
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collection before submitting the collection to OMB for approval. To
comply with this requirement, we are publishing this notice of a
proposed data collection as described below.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden of the
proposed collection of information; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; (d) ways to
minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services
to provide information. Burden means the total time, effort, or
financial resources expended by persons to generate, maintain, retain,
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; to develop, acquire,
install and utilize technology and systems for the purpose of
collecting, validating and verifying information, processing and
maintaining information, and disclosing and providing information; to
train personnel and to be able to respond to a collection of
information, to search data sources, to complete and review the
collection of information; and to transmit or otherwise disclose the
information.
Proposed Project
The National Health and Nutrition Examination Survey (NHANES), (OMB
No. 0920-0950, expires 12/31/2017)--Revision--National Center for
Health Statistics (NCHS), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
Section 306 of the Public Health Service (PHS) Act (42 U.S.C.
242k), as amended, authorizes that the Secretary of Health and Human
Services (DHHS), acting through NCHS, shall collect statistics on the
extent and nature of illness and disability; environmental, social and
other health hazards; and determinants of health of the population of
the United States. The National Health and Nutrition Examination
Surveys (NHANES) have been conducted periodically between 1970 and
1994, and continuously since 1999 by the National Center for Health
Statistics, CDC. Annually, approximately 14,410 respondents participate
in some aspect of the full survey. Up to 3,500 additional persons might
participate in tests of procedures, special studies, or methodological
studies (Table 1). Participation in NHANES is completely voluntary and
confidential. A three-year approval is requested.
NHANES programs produce descriptive statistics which measure the
health and nutrition status of the general population. Through the use
of physical examinations, laboratory tests, and interviews NHANES
studies the relationship between diet, nutrition and health in a
representative sample of the United States. NHANES monitors the
prevalence of chronic conditions and risk factors. NHANES data are used
to produce national reference data on height, weight, and nutrient
levels in the blood. Results from more recent NHANES can be compared to
findings reported from previous surveys to monitor changes in the
health of the U.S. population over time. NCHS collects personal
identification information. Participant level data items will include
basic demographic information, name, address, social security number,
Medicare number and participant health information to allow for
linkages to other data sources such as the National Death Index and
data from the Centers for Medicare and Medicaid Services (CMS).
A variety of agencies sponsor data collection components on NHANES.
To keep burden down, NCHS cycles in and out various components. The
2017-2018 NHANES physical examination includes the following
components: Anthropometry (all ages), 24-hour dietary recall (all
ages), physician's examination (all ages, blood pressure is collected
here), oral health examination (ages 1 and older), and hearing (ages 6-
19 and 70+).
While at the examination center additional interview questions are
asked (6 and older), a second 24-hour dietary recall (all ages) is
scheduled to be conducted by phone 3-10 days later. In 2017 we plan to
add a liver elastography (ultrasound) exam with a set of alcohol
questions to complement this exam, an Oral Human Papilloma Virus (HPV)
follow-up, and cycle back in bone density for hip and spine into the
Dual X-ray Absorptiometry (DXA) exam for (ages 50+). The osteoporosis
questionnaire will also cycle back into NHANES to complement the
changes to the DXA exam. These questions will be asked of those 40+ In
addition, the age range for the existing DXA total body scan will be
changed from 6-59 years to 8-69 years.
NHANES plans to conduct a blood pressure methodology study. The
study population will be NHANES participants aged 6 and older who agree
to come to the Mobile Examination Center (MEC). The survey would also
like to conduct an Ambulatory Blood Pressure Pilot Study among NHANES
participants ages 18 and older.
The bio-specimens collected for laboratory tests include urine,
blood, vaginal and penile swabs, oral rinses and household water
collection. Serum, plasma and urine specimens are stored for future
testing, including genetic research, if the participant consents.
NHANES 2017-18 plans to add three Phthalates in urine (ages 3+), nine
Urinary flame retardants in urine (ages 3+), one Insect repellant in
urine (ages 3+), one Volatile organic compound (VOC) metabolite in
urine (ages 3+), eighteen Tobacco biomarkers in urine (ages 3+), two
Metals in urine (ages 3+), Vitamin C in serum (ages 6+), Vitamins A, E,
and carotenoids in serum (ages 6+), Unsaturated Iron Binding Capacity
(UIBC)/Total Iron Binding Capacity (TIBC) in serum (ages 12+), and
Congenital cytomegalovirus (CMV) in sera (ages 1-5). Consent to store
DNA is cycling back into NHANES.
In addition metals in whole blood are changing from a one-half
sample to a full sample (ages 1+). Polycyclic Aromatic Hydrocarbons
(PAHs) are being discontinued in the smoker oversample subgroup,
however testing will continue in a \1/3\ subsample of general NHANES
participants.
The 2017-18 survey will also bring back the Flexible Consumer
Behavior Survey Phone follow-Up questionnaire for participant ages 1+.
This takes place in the home after the second dietary recall is
completed.
The following major examination or laboratory items, that had been
included in the 2015-2016 NHANES, were cycled out for NHANES 2017-2018:
Pubertal maturation, oral glucose tolerance test (OGTT), dual X-ray
absorptiometry scans for vertebral fractures and aortic calcification,
three metals in serum and three hormones and binding proteins.
Most sections of the NHANES interviews provide self-reported
information to be used either in concert with specific examination or
laboratory content, as independent prevalence estimates, or as
covariates in statistical analysis (e.g., socio-demographic
characteristics). Some examples include alcohol, drug, and tobacco use,
sexual behavior, prescription and aspirin use, and indicators of oral,
bone, reproductive, and mental health. Several interview components
support the nutrition monitoring objective of
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NHANES, including questions about food security and nutrition program
participation, dietary supplement use, and weight history/self-image/
related behavior.
In 2017-2018, we also plan to conduct a Dietary Supplement Imaging
pilot study, as well as implement multi-mode screening and electronic
consent procedures in NHANES. The consent for birth certificate linkage
that had been included in previous NHANES will be dropped from NHANES
2017-2018.
There is no cost to respondents other than their time.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
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Individuals in households...................... NHANES Questionnaire................... 14,410 1 2.5 36,025
Individuals in households...................... Blood Pressure Methodology Study Phase 1,404 1 30/60 702
1.
Individuals in households...................... Blood Pressure Methodology Study Phase 2,000 1 30/60 1,000
2.
Individuals in households...................... Ambulatory Blood Pressure Pilot Study.. 1,200 1 25 30,000
Individuals in households...................... Oral HPV rinse Follow-up Study 6 months 2,880 1 10/60 480
(estimated 80% of original sample of
3600).
Individuals in households...................... Oral HPV rinse Follow-up Study 12 2,520 1 10/60 420
Months (estimated 70% of original
sample).
Individuals in households...................... Oral HPV rinse Follow-up Study 18 2,160 1 10/60 360
months (estimated 60% of original
sample).
Individuals in households...................... Oral HPV rinse Follow-up Study 24 1,800 1 10/60 300
Months (estimated 50% of original
sample).
Individuals in households...................... Flexible Consumer Behavior Survey Phone 5,000 1 20/60 1,667
Follow-Up.
Individuals in households...................... Special Studies........................ 3,500 1 3 10,500
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Total...................................... ....................................... .............. .............. .............. 81,454
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Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-12009 Filed 5-20-16; 8:45 am]
BILLING CODE 4163-18-P